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Restrictions on medicated feeds coming to farms

By the end of this year, hundreds of antimicrobial applications for livestock will change to add veterinarian oversight and remove approval for growth and efficiency uses.

Dr. William T. Flynn, deputy director for science policy at the Food and Drug Administration’s Center for Veterinary Medicine, said the change is a substantial departure from the way antimicrobials have been used in U.S. agriculture for decades.

“It’s a big country, and there’s a lot of farms and ranches out there to get this information to,” he said. “And that was a key reason why we set out a three-year timeline to put these changes into place.”

Agency officials announced in December 2013 that pharmaceutical companies would have three years to consent to drug approval changes that would remove permission for livestock production use, in feed or water, of any drugs that are in the same antimicrobial classes used in human medicine and remove over-the-counter access to those drugs. They warned that companies could face administrative action if they failed to comply, and by June 2014, all affected companies had agreed to make the changes, planned for late this year. Specific dates were unavailable at press time.

I’m optimistic that we’ve gotten information out to key folks. In the end, whether we reached everyone, that’s certainly a challenge. And I suspect there’s still going be issues that we’re going to have to face as we—as these changes go into effect.”

The agency is trying to reduce the development of antimicrobial resistance by limiting antimicrobial uses to those with medical importance: disease treatment, control, and prevention.

Dr. Flynn said national associations for livestock owners, veterinarians, and feed industries have worked to tell their members about the restrictions, and FDA employees have answered questions at meetings across the country since the 2013 announcement.

“I’m optimistic that we’ve gotten information out to key folks,” he said. “In the end, whether we reached everyone, that’s certainly a challenge. And I suspect there’s still going be issues that we’re going to have to face as we—as these changes go into effect, that there are going to be some folks out there who haven’t gotten all the information they need or haven’t made the necessary adjustments. I think we understand that, and we’re just going to have to work through that the best we can.”

The changes will expand use of veterinary feed directives, prescription-like orders that will be used for many of the medicated feeds that had been available over the counter. Affected antimicrobials administered in water will require prescriptions.

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​Dr. William T. Flynn (Courtesy of FDA CVM)

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Dr. K. Fred Gingrich II, former president and incoming executive vice president of the American Association of Bovine Practitioners, said veterinarians have had ample opportunities to learn about the coming changes, and he recommends that those who work with livestock use educational resources from the AVMA, FDA, and AABP to prepare to provide drugs through VFDs. Producers should ask their veterinarians whether they have established a veterinarian-client-patient relationship, he said.

He expects a minority of veterinarians and livestock owners are unaware of the pending restrictions and that awareness will be lowest among those in isolated areas, particularly mixed animal practitioners with occasional food animal work and owners of small numbers of livestock.

“I’m not sure what else we can do to get this message out there—more than what we already have—as far as veterinary organizations, extensions, FDA, Farm Foundation, local and professional media,” he said.

The FDA also revised the VFD process to improve efficiency. Prior to the revisions, only three drugs had VFD label indications: avilamycin in swine, florfenicol in swine and fish, and tilmicosin in swine and cattle.

Veterinarians and clients

Dr. Gingrich supports the pending restrictions because veterinarians should have an integral role in all drug administration on cattle operations. Writing VFDs will require more work, he said, but he thinks creating them will become as easy as writing prescriptions.

“For the majority of producers in the country, for their animals, I don’t think it’ll have any major deleterious effects on animal health,” he said.

But he has concerns for animals living on farms that lack veterinarians—whether by the owners’ choice or because of a lack of nearby veterinarians—and on farms that rely on illegal uses made possible by over-the-counter medications. He stressed that veterinarians do not support illegal uses.

“A veterinarian is not going to be able to authorize indications that are not on the label, and there’s currently no product that’s labeled for pinkeye or foot rot control,” Dr. Gingrich said.

Any increase in the use of individual treatments would be challenging when cattle are on ranges, he said. And he remained uncertain whether drug labels would allow certain uses, such as administering chlortetracycline to control anaplasmosis or using tylosin to control liver abscesses among finishing cattle.

Dr. John Killian, owner of Bar-K Veterinary Clinic in Stratford, Texas, expects small increases in paperwork and bureaucracy and maybe an increase in antimicrobials delivered by injection. He focuses on large animal work, mostly with beef ranchers, stockers, and feed yards.

Like Dr. Gingrich, Dr. Killian thinks the coming changes in antimicrobial availability have had adequate advertisement. But he expects some producers may discover the change when they try to buy medicated feeds at retail stores.

He also expects livestock owners will become accustomed to the requirements, so that VFDs will become a regular part of his business.

Dr. Tom Burkgren, executive director of the American Association of Swine Veterinarians, said veterinarians could visit more farms and gain clients. That could benefit pigs, although potentially at an increased cost for clients, he said. But most swine veterinarians he knows have full workloads, and the economic benefits for them are unlikely to be substantial, he said.

He also recommends that veterinarians, livestock producers, and feed mills improve communication before January.

Mary Thompson, communications vice president for Farm Foundation, a nonprofit and nonadvocacy charitable organization, said in September that her organization was among those in the feed and livestock industries developing educational campaigns about the pending restrictions on sales of antimicrobials through retail feed, farm, and tractor supply stores. Farm Foundation had published in January the report “Stewardship of antimicrobial drug use in food-producing animals,” which describes potential knowledge gaps among those working in agriculture and difficulties in establishing VCPRs as well as the potential for the VCPR requirement to strengthen relationships between veterinarians and their clients.

“At the same time, veterinarians will take on increased responsibility and liability as they will be required to maintain the original copy of each VFD,” it states. “This may require investments in new record keeping systems and increased insurance costs for veterinary practices.”

Animal health

Antimicrobial use will decrease in the swine industry, Dr. Burkgren said, adding that some soon-to-be lost production uses have health benefits. He said pork producers in some European countries began to observe health challenges among weaning-age pigs, such as increases in enteric and respiratory disease, after adopting similar limitations.

I don’t think it’ll have any major deleterious effects on animal health.”

Dr. Killian also said antimicrobials alleviate animal suffering, and waiting until illness arrives can increase suffering.

Concerns about animal health have been raised since the FDA proposed reducing antimicrobial access and use, Dr. Flynn said.

“That’s something that we’ve been sensitive to as we’ve developed and implemented our strategy,” he said.

Dr. Flynn noted that the new restrictions eliminate antimicrobial uses intended for production-enhancing effects, not for health effects.

He also cautioned against predicting the effects of the U.S. changes on the basis of other countries’ experiences because of differences in their agriculture systems and practices, settings, scale, and types of restrictions implemented. Dr. Flynn noted that withdrawing growth-promotion uses in some countries led only to temporary increases in disease incidence and therapeutic antimicrobial administration.

“I think it’s a little bit hard to extrapolate from what has happened—what has been seen in response to similar types of actions in other countries around the world,” he said.

He hopes the three-year phase-in and addition of veterinarian oversight will minimize animal health repercussions, and the FDA will work to fill any gaps in animal health needs.

“We certainly support and recognize that antibiotics have an important role for preventing disease, including treating, controlling, and preventing disease,” he said.

Veterinarians are examining management practices, in part, because of these changes, Dr. Burkgren said. They will have fewer tools but still can adjust weaning ages, increase the use of vaccination, and increase efforts to eliminate pathogens.

“We have to question the necessity, the efficacy, and the stewardship of those uses,” he said.

Next steps

Asked about antimicrobial use among importers, Dr. Flynn said the FDA and other federal agencies have goals to work with other countries toward improving their measures to address the global problem of antimicrobial resistance. That includes advocating stronger measures to control and manage resistance within agriculture and health care systems, including human health care.

The FDA is among federal agencies involved in a White House–backed effort to reduce the risk of antimicrobial resistance by not only reducing antimicrobial use in agriculture but also increasing stewardship in human and animal health care facilities. The collaboration involves the Department of Health and Human Services, the Department of Agriculture, and the Environmental Protection Agency (see JAVMA, Nov. 15, 2014).

Dr. Flynn also said he and others at the FDA see a need for more work within the U.S. to ensure antimicrobials are used under appropriate conditions. Disease prevention uses are important, he said, but the agency wants to ensure the available prevention uses are judicious, targeted, and overseen by veterinarians.

“I would say that there’s more work that we need to do,” he said. “We need to continue to look at these products.”

He hopes the FDA will collaborate with livestock producers and veterinary associations, among others, toward managing antimicrobial resistance.

“We need to make sure that these products remain effective so that they’re still available for us to use not only to treat human infections but also disease in animals,” he said.

FDA officials also published notice in September that they are considering establishing treatment durations for antimicrobials that are approved for therapeutic uses but lack defined limits (seestory).

Correction: An earlier version of this article contained an inaccurate description of Farm Foundation.